Brain StimulationNCT06694909
Glutamate Modulation of tDCS Over Premotor Cortex Combined With Peripheral Nerve Stimulation Promoted Observation-execution-related Cortical Excitability and Motor Learning
A study testing tDCS + PNS with action observation and tDCS + PNS without action observation in people with Brain Stimulation and Peripheral Nerve Stimulation, run by Beijing Sport University at 1 site in China.
Trial summary
This study aimed to investigate whether concurrent tDCS over the PMC and PNS during action observation enhance observation-execution-related motor cortex excitability and improve motor performance, and to explore the underlying mechanism Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Stimulation, Peripheral Nerve Stimulation, Motor Observation
- What is being tested?
- tDCS + PNS with action observation and tDCS + PNS without action observation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2017to 14 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal or corrected-to-normal vision
- right-handed
Who cannot join
- pregnancy
- a history of epilepsy
- implanted medical devices
- history or presence of neurological, psychiatric or musculoskeletal disorders, other medical conditions, and left-handedness
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to investigate whether concurrent tDCS over the PMC and PNS during action observation enhance observation-execution-related motor cortex excitability and improve motor performance, and to explore the underlying mechanism
- Being tested
- tDCS + PNS with action observation, sham tDCS + sham PNS with action observation, tDCS + PNS without action observation, sham tDCS + PNS with action observation, tDCS + sham PNS with action observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS + PNS with action observationDevice
tDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation
sham tDCS + sham PNS with action observationDevice
tDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation
tDCS + PNS without action observationDevice
tDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation
sham tDCS + PNS with action observationDevice
tDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation
tDCS + sham PNS with action observationDevice
tDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| tDCS + PNS with action observation | Experimental | Not described Receives: Device: tDCS + PNS without action observation |
| sham tDCS + sham PNS with action observation | Experimental | Not described Receives: Device: sham tDCS + sham PNS with action observation |
| tDCS + PNS without action observation | Experimental | Not described Receives: Device: sham tDCS + PNS with action observation |
| sham tDCS + PNS with action observation | Active comparator | Not described Receives: Device: tDCS + PNS with action observation |
| tDCS + sham PNS with action observation | Active comparator | Not described Receives: Device: tDCS + sham PNS with action observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor-evoked potentials
Measured: Before interventions, and immediately after interventions
intracortical facilitation assessed by transcranial magnetic stimulation
Measured: Before interventions, and immediately after interventions
short-interval intracortical inhibition assessed by transcranial magnetic stimulation
Measured: Before interventions, and immediately after interventions
Reaction times of action execution blocks
Measured: immediately after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start17 Oct 2017
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694909
- Sponsor's protocol ID
- GMOTOPCCWPNSPOERCEAML
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamate Modulation of tDCS Over Premotor Cortex Combined With Peripheral Nerve Stimulation Promoted Observation-execution-related Cortical Excitability and Motor Learning
- ClinicalTrials.gov ID
- NCT06694909
- Acronym / sponsor ID
- GMOTOPCCWPNSPOERCEAML
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to investigate whether concurrent tDCS over the PMC and PNS during action observation enhance observation-execution-related motor cortex excitability and improve motor performance, and to explore the underlying mechanism
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| tDCS + PNS with action observation | Experimental | Device: tDCS + PNS without action observation |
| sham tDCS + sham PNS with action observation | Experimental | Device: sham tDCS + sham PNS with action observation |
| tDCS + PNS without action observation | Experimental | Device: sham tDCS + PNS with action observation |
| sham tDCS + PNS with action observation | Active comparator | Device: tDCS + PNS with action observation |
| tDCS + sham PNS with action observation | Active comparator | Device: tDCS + sham PNS with action observation |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal or corrected-to-normal vision
- right-handed
Key exclusion criteria (4 listed)
- pregnancy
- a history of epilepsy
- implanted medical devices
- history or presence of neurological, psychiatric or musculoskeletal disorders, other medical conditions, and left-handedness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS + PNS with action observationtDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation | Device | sham tDCS + PNS with action observation |
| sham tDCS + sham PNS with action observationtDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation | Device | sham tDCS + sham PNS with action observation |
| tDCS + PNS without action observationtDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation | Device | tDCS + PNS with action observation |
| sham tDCS + PNS with action observationtDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation | Device | tDCS + PNS without action observation |
| tDCS + sham PNS with action observationtDCS: transcranial direct current stimulation; PNS: peripheral nerve stimulation | Device | tDCS + sham PNS with action observation |
Primary outcome
Motor-evoked potentials
Time frame: Before interventions, and immediately after interventions
intracortical facilitation assessed by transcranial magnetic stimulation
Time frame: Before interventions, and immediately after interventions
short-interval intracortical inhibition assessed by transcranial magnetic stimulation
Time frame: Before interventions, and immediately after interventions
Reaction times of action execution blocks
Time frame: immediately after interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS + PNS with action observation and tDCS + PNS without action observation in people with Brain Stimulation and Peripheral Nerve Stimulation, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor-evoked potentials (time frame: Before interventions, and immediately after interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.